1. Field of the Invention
The present invention relates generally to the field of eyedrop dispensing devices. The present invention relates more specifically to devices for facilitating the proper positioning of an eyedrop dispensing device and the automated dispensing of a fixed quantity of sterile eyedrop solution. The present invention also relates more specifically to improvements in an eyedrop delivery system including drop delivery confirmation, variable bottle size accommodation, and improved cushioned orbital lobe contact surfaces.
2. Description of the Related Art
Devices for dispensing eyedrop solutions are known. Generally, a bottle of eyedrop solution includes a drop dispenser that is built into the exit orifice of the container. To dispense the solution, the user squeezes the bottle forcing solution out of the exit orifice and into his or her eye. Many users have trouble with dispensing eyedrops from standard dispensing bottles. The user has a tendency to blink when the drop is about to enter the eye, causing the drop to miss the eye and land on a closed lid or to one side of the eye. Therefore, eyedrop solution is frequently wasted due to the user blinking during the attempted application and the user ends up with eyedrop solution streaming down his or her face. Problems also occur when the user dispenses too much eyedrop solution (too many drops) accidentally. The user may also think that they have dispensed a drop of solution properly when they may not have. Normally, the eye will only hold about 0.6 of a drop. Therefore, some of the drop will typically go onto the eyelid. It is extremely difficult for the user to know whether the proper 60% of the drop actually landed in the eye. In addition, the size of a drop for a given solution may vary significantly in size.
Besides improper usage and subsequent inadequate treatment, waste is another consideration with currently available eyedrop administration. While some eyedrop solutions are sufficiently inexpensive that manufacturers can plan on some waste by the user while designing packaging for the product and fixing a selling price, other eyedrop solutions, being much more expensive, can dramatically increase the cost of eye care if sufficient measures are not taken to reduce the waste normally associated with the administration of eyedrop solutions.
There are, in addition, a number of problems associated with maintaining the sterility of solutions that are dispensed from a large container through a dropper tip that may become contaminated by exposure or contact. All multi dose vials sold in the U.S. contain antiseptic compounds to protect the solution against bacterial and viral contamination. Moreover, organic antiseptics do not kill all bacteria or viruses. These antiseptics are often irritating and may be toxic to the sensitive tissues surrounding and within the eye. For these reasons, individual dosages of sterile eyedrop solutions may be preferable to a simple container holding a quantity of eyedrop solution that may be subject to waste and may also be subject to contamination once the eye drop bottle is opened.
A number of efforts have attempted to resolve the contamination problem. Thomas Keen, in his U.S. Pat. No. 4,543,096, discloses a dispenser with an eyelid opening device. The user is required to place a pair of lid spreading legs on the edge of the eyelids dangerously close to the eye and then press a lever arm to keep the eyelids apart. It is nearly impossible to exert enough pressure on the edge of the eyelid to keep the eye open without injuring the eye. Thomas Sherman, in his U.S. Pat. No. 6,371,945, discloses an attachment for a bottle that includes a ring intended to help align the bottle with the eye. However, no attempt is made to hold the eyelids open. Gary Campagna, in his U.S. Pat. No. 3,934,590, shows a tripod like device for aligning the solution bottle over the user's eye. No attempt is made to hold the lid open. James Davidian, in his U.S. Pat. No. 6,595,970, shows a device for dispensing eye drops. He proposes a dispensing arm, one side of which includes an indentation that receives the user's nose, the other side of which accepts a dispensing bottle. The bottle includes a pair of arms which, when squeezed, impinge on the side walls of the bottle forcing solution out of the bottle and into the user's eye. No attempt is made to hold the user's eyelid open. U.S. Pat. No. 7,191,916 issued to Julia Clifford et al. shows a dispenser that attempts to control the amount of drops that exit a solution holding bottle. The bottle has retractable apertures that capture and release a drop of solution. The devices disclosed in U.S. Pat. No. 4,927,062 (Walsh); U.S. Pat. No. 6,041,978 (Hagele); U.S. Pat. No. 6,010,488 (Deas); and U.S. Pat. No. 4,834,727 (Cope) as well as U.S. Pat. No. 5,902,292 (Feldman), all attempt to position an eyedrop bottle in a correct location above a person's eye, but none include a means to help hold the user's eye lids spread apart in an open position. U.S. Pat. No. 4,321,916 (McKee) discloses an eyelid retractor that is used during ocular surgery or the like. It is not designed to be used with the dispensing of eyedrop solution.
None of the above cited devices safely holds the user's eyelids open while dispensing eyedrops from a standard eyedrop bottle. Additionally, none of the above mentioned patents describe a device that allows the user to dispense a portioned amount of eyedrop solution in an automatic and repeatable fashion. None of the above cited inventions dispenses a precise amount of eyedrop solution and simultaneously holds the user's eyelids open while doing so.
There has been little, if any, effort in the prior art to provide an efficient means for dispensing single dosages of sterile eyedrop solution accurately and completely into the user's eye. What systems that have been developed are generally expensive and involve a one-time use, where the complex device must be disposed of after the individual dosage has been dispensed. None of the above references provide an automated mechanism for dispensing a series of individual measured doses of eyedrop solution under sterile or near sterile conditions into the user's eye accurately and completely along with direct confirmation of the appropriate dispensing action.
Various efforts have been made to provide confirmation of eyedrop delivery to the eye. In the simplest form the user holds a bottle over the open eye, squeezes the bottle, and hopes that a drop finds its way onto the eyeball. Recent improvements to eyedrop delivery are provided by the system disclosed by the same Applicant of the present invention in the various Related Applications cross referenced above.
The Automated Incremental Eyedrop Delivery System with Eyelid Retracting Legs of the referenced disclosures provide elements to assist with keeping the eye open, electromechanical drive system for automated activation of the delivery system, and are designed to utilize existing eyedrop bottles that may vary slightly in size. The present disclosure also provides a number of improvements that help to assure not only that a single drop or a known number of drops are dispensed from the bottle and that the eye remains open, but also that the eyedrop(s) landing on the eye can be confirmed.